Pharmacy and Therapeutics Committee Meeting Summary - November 2, 2007

Agenda and Introduction

The Medicaid Pharmacy & Therapeutics Committee met on Friday, November 2, 2007 from 8:00 a.m. to 4:00 p.m. in Meeting Room 6, Concourse, Empire State Plaza, Albany, New York.

Linda Jones, NYS Department of Health, Office of Health Insurance Programs (DOH/OHIP), noted that for today's meeting, William Scheer will be the acting Chairperson and Andrew Flynn will be the acting Co-chairperson.

Anthony Merola, (DOH/OHIP), reiterated for the re-review meetings, only new clinical information since the previous review of the therapeutic class should be submitted for review by the Committee, and documents should not be sent directly to Committee members, but to DOH for distribution to all Committee members.

A. Background Materials Provided:

The Committee was provided copies of written materials submitted by interested parties in advance of the meeting.

B. Public Comment Period:

The following speakers provided comment to the committee:

1. Sanders, Alan, MD, Upstate Infectious Diseases Associates, Albany, NY
2. Papariello, Anthony, PharmD, Regional Medical Scientist, GlaxoSmithKline, New York, NY
3. Baran, Daniel, MD, Senior Medical Director, Merck & Co., Shrewsbury, MA
4. Smith, Thomas, MD, Director of Pulmonary and Critical Care Medicine at Albany Medical College, Albany, NY
5. Goldman, Donna, MD, Senior Medical Liaison, Roche, Nutley, NJ
6. Tevlin, Brian, PharmD, Medical Science Liaison, Virology, Schering-Plough Corp., Kenilworth, NJ
7. Byrne, Sean, PA, Riverdale Gastroenterology & Liver Diseases, Bronx, NY
8. Horn, James, MD, Capital District Renal Physicians, Albany, NY
9. Hamilton, Ross, MD, Senior Medical Science Liaison, Shire Pharmaceuticals, New York, NY
10. Eggleston, Steve, PharmD, Regional Medical Scientist, GlaxoSmithKline, Albany, NY
11. Gardner, Jeffrey, MD, Pediatrician at St. Mary's Hospital & Johnstown Family Health Center, Johnstown, NY
12. Sproles, Christine, PharmD, Account Director, Sepracor Inc., Fortville, IN
13. Marin, Matthew, MD, MPH, Senior Director - Respiratory, AstraZeneca, Denville, NJ
14. Schroeder, Scott, MD, Division of Pulmonary Medicine - Department of Pediatrics, Albany Medical Center, Albany, NY
15. Dac-Korytko, Ia, Senior Regional Scientific Manager, AstraZeneca, Buffalo, NY
16. Dietrich, Gary, MD, Medical Director, Merck/Schering-Plough, Granby, MA

C. Key issues raised by interested parties and the Pharmacy and Therapeutics Committee pertaining to the clinical re-review of the following therapeutic classes:

Public comments:

Leukotriene Modifiers:

• The Committee was asked to consider information regarding clinical trial results (indications, efficacy, duration of action, pharmacokinetics, use in adult and pediatric patients, and adherence), as well as the revised National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3 and Global Initiative for Asthma (GINA).

Anti-Virals (used in the treatment of Herpes):

• The Committee was asked to consider information regarding clinical trial results (indications including primary and recurrent infections, suppression and prevention of transmission of genital herpes, safety, efficacy, pharmacokinetics, and bioavailability), as well as recommendations from the Centers for Disease Control (CDC) and American College of Obstetricians and Gynecologists (ACOG) guidelines.

Hepatitis C Agents:

• The Committee was asked to consider information regarding clinical trial results (indications, dosing [weight based vs. fixed], length of treatment per genotype, efficacy with ribavirin, relapse rates, safety, adverse events, tolerability, adherence, sustained virologic response [SVR]), as well as use in special populations (i.e. dialysis and substance abuse patients and patient support programs).

Phosphate Binders/Regulators:

• The Committee was asked to consider information regarding clinical trial results (efficacy, mechanism of action, safety, the importance of the calcium/phosphorus product, adverse effects, pharmacokinetics, pill burden, and adherence).

Beta ₂ Adrenergic Agents - Inhaled Short Acting:

• The Committee was asked to consider information regarding clinical trial results (indications, efficacy in adults and pediatrics, safety, dosing, product stability, onset and duration of action), as well as the phase-out of inhalers containing chlorofluorocarbons (CFCs), and inhaler devices containing dose counters.

Beta ₂ Adrenergic Agents - Inhaled Long Acting:

• The Committee was asked to consider information regarding clinical trial results (indications, safety, dosing, efficacy, onset and duration of action, the need for rescue medications, and adverse effects including the FDA warning).

Corticosteroids - Inhaled:

• The Committee was asked to consider information regarding clinical trial results (indications, safety, efficacy, dosing, the boxed warning when in combination with LABAs, onset of action, ease of use, pregnancy rating, the need for rescue medications), as well as the revised National Asthma Education and Prevention Program (NAEPP) Expert Panel Report 3 and inhaler devices containing dose counters.

Cholesterol Absorption Inhibitors (CAIs):

• The Committee was asked to consider information regarding clinical trial results (indications, efficacy as monotherapy or in combination therapy, mechanism of action, safety).

D. Clinical Presentation and Discussion

Gerald Gartlehner, MD, MPH, RTI-UNC Evidence-based Practice Center (UNC EPC); Susan L. Norris, MD, MPH, Oregon Health & Science University, Evidence-based Practice Center (OHSU EPC); Barbara Rogler, PharmD, MS, First Health Services Corporation; Robert Correia, PharmD, NYS Department of Health, Office of Health Insurance Programs (DOH/OHIP)

1. Re-review of the Leukotriene Modifier therapeutic class

Drugs Affected: Accolate (zafirlukast), Singulair (montelukast)

Dr. Rogler mentioned the NAEPP updated guidelines and spoke about the place in therapy of the leukotriene modifiers as defined in the guidelines.

Dr. Correia provided the Department's clinical review of new information for this category. He addressed the new asthma guidelines which identify all the leukotriene modifiers as alternative, but not preferred, therapy in step 2 or higher care, and an alternative, but not preferred, adjunct to inhaled corticosteroids (ICS) in patients 12 years of age and older. He indicated that no new comparative evidence was found, and little new clinical information, with nothing new to differentiate the drugs in this class.

2. Re-review of the Hepatitis C Agent therapeutic class

Drugs Affected: PEG-Intron (peginterferon alfa-2b), Pegasys (peginterferon alfa-2a)

Dr. Rogler indicated that she found no new clinical information since the last review.

Dr. Correia noted that OHSU completed a new drug class review for the Pegylated Interferons for Chronic Hepatitis C in May 2007. Their conclusion was that the overall quality of the evidence available was fair to poor, was insufficient to determine whether dual therapy of ribavirin with either pegylated interferon differs in efficacy or safety, and indicated that most trials had methodological shortcomings. He also indicated that the Department's re-review found no new comparative evidence to differentiate effectiveness between the two products, and that there is still no published data to demonstrate either product as superior overall, although each may demonstrate preferential characteristics within specific subpopulations.

A committee member asked if there were any studies indicating that flat dosing was less effective than weight based dosing. In response, it was noted there were no studies, and it was difficult to compare in terms of sustained virologic response because the ribavirin dosing often varies.

3. Re-review of the Third Generation Cephalosporin therapeutic class

Drugs Affected: Cedax (ceftibuten), cefdinir, cefpodoxime proxetil, Omnicef (cefdinir), Suprax (cefixime), Spectracef (cefditoren), Vantin (cefpodoxime proxetil)

Dr. Rogler noted two new generic medications (cefdinir capsule/suspension and cefpodoxime suspension) and the new CDC guidelines for the treatment of gonorrhea.

Dr. Correia provided the Department's clinical review of new information for this category. He indicated no new comparative evidence was found to differentiate effectiveness between the products. He noted the drug class may be clustered into groups according to relative gram-positive or gram-negative bacterial activity, with none of the drugs demonstrating an overall advantage, and suggested that drugs in both bacterial spectrum groups be represented as preferred drugs.

4. Re-review of the Otic Fluoroquinolone therapeutic class

Drugs Affected: Cipro HC (ciprofloxacin/hydrocortisone), Ciprodex (ciprofloxacin/dexamethasone), Floxin (ofloxacin)

Dr. Rogler noted the addition of one new generic medication to this class: ofloxacin 0.3% otic solution. She indicated that she found no other new clinical information since the last review of this therapeutic class.

Based on the Department's clinical review of new information for this category, Dr. Correia noted that no new comparative evidence was found to differentiate effectiveness between the three products. He indicated all three are effective and may have subtle differences in specific indications or symptomatic relief for particular patient populations, with none of the products demonstrating an overall advantage.

5. Re-review of the Anti-Emetic therapeutic class

Drugs Affected: Anzemet (dolasetron), Kytril (granisetron), ondansetron, Zofran (ondansetron)

Dr. Rogler noted the addition of one new generic (ondansetron) to this class. She also mentioned the American Society of Clinical Oncology (ASCO) 2006 updated anti-emetic guidelines which indicate there are still questions regarding a possible superior agent in this class.

Dr. Correia also noted the new generic medication in this class. He stated that after the Department's review, no new comparative evidence was found to differentiate effectiveness between the three drugs, and that all are effective, with none demonstrating an overall advantage.

6. Re-review of the Second Generation Antihistamine therapeutic class

Drugs Affected: Allegra/Allegra-D (fexofenadine), Clarinex/Clarinex-D (desloratadine), Claritin/Claritin-D (loratadine), loratadine/loratadine D, fexofenadine, Semprex-D (acrivastine), Xyzal (levocetirizine), Zyrtec/Zyrtec-D (cetirizine)

Dr. Rogler discussed expanded formulations and indications as well as dosing for Clarinex Syrup and Reditabs, and Allegra Suspension. She also noted the new product in this class, Xyzal, an isomer of Zyrtec. She discussed indications and dosing for Xyzal, and noted there are currently no head-to-head trials with this product published.

Dr. Correia provided the Department's clinical review of new information for this category. He spoke about the new product in this class, levocetirizine, noting it is an isomer of cetirizine, with little comparative evidence available, and none found to demonstrate any clinically significant difference in effectiveness of levocetirizine versus cetirizine. He also mentioned the contraindications for levocetirizine. He noted the OHSU drug class review illustrated the lack of available data on comparative efficacy of these drugs, and a May 2007 OHSU interim literature scan found no new comparative evidence for drugs in this therapeutic class. He concluded that overall, there remains no significant new clear clinical information demonstrating overall superiority for any of the drugs in this class since the last time it was re-reviewed.

There was discussion among Committee members regarding the new product in this class, and it was noted that Zyrtec is scheduled to lose patent protection, and may become an over-the-counter product.

7. Re-review of the Cholesterol Absorption Inhibitors (CAIs) therapeutic class

Drug Affected: Zetia (ezetimibe)

Dr. Rogler indicated that she found no new clinical information since the last review of this therapeutic class.

Dr. Correia provided the Department's clinical review of new information for this category. He noted there is only one drug in this class, so there is no basis for comparative review. He indicated Zetia is currently covered by Medicaid both as an individual drug and as part of a combination product, and maintaining the CAI class on the PDP minimizes uncertainty with regard to the availability of Zetia for use alone or in combination with any statin drug. He concluded no new clinical evidence was found which should suggest a change in status of this therapeutic class.

8. Re-review of the Phosphate Binders/Regulator therapeutic class

Drugs Affected: Fosrenol (lanthanum), Phoslo (calcium acetate), Renagel (sevelamer)

Dr. Rogler indicated that she found no new clinical information since the last review of this therapeutic class.

Dr. Correia indicated that no new comparative evidence was found to differentiate between the three products. He noted that as discussed in the previous review, the drugs under consideration represent two major treatment approaches, and each of the drugs has individual benefits or risks depending on stage of disease or patient comorbidity. He concluded that any of the three drugs may have advantages or be preferable at different stages of disease progression, with none of these drugs demonstrating overall advantages at all stages or in all situations.

9. Re-review of the Beta ₂ Adrenergic Agents - Inhaled Short Acting therapeutic class

Drugs Affected: Accuneb (albuterol), albuterol, Alupent (metaproterenol), Maxair Autohaler (pirbuterol), metaproterenol, ProAir HFA (albuterol), Proventil (albuterol), Proventil HFA (albuterol), Ventolin HFA (albuterol), Xopenex (levalbuterol), Xopenex HFA (levalbuterol)

Dr. Norris, OHSU, presented an overview of the OHSU DERP Drug Class Review on Beta ₂ - Agonists, both Short Acting and Long Acting, dated November, 2006. The report evaluated clinical studies of efficacy and effectiveness of Beta ₂ agonists in asthma, exercise-induced asthma (EIA), and chronic obstructive pulmonary disease (COPD). Adult and pediatric studies were evaluated, as were studies evaluating subpopulations including gender, age, race and patients with comorbidities. Studies evaluating differences in safety or rates of adverse effects in adult and pediatric patients in an outpatient setting were also evaluated. In the majority of studies included in the report, there was either no significant difference between drugs, insufficient evidence to draw a conclusion, inconsistent results, or no data.

Dr. Rogler noted the November 2006 update of the GINA guidelines changing the focus from asthma severity to asthma control. She explained the place in therapy of the short acting Beta ₂ agonists, according to those guidelines. She also mentioned the Montreal Protocol proposed new propellants such as hydrofluoroalkane (HFA) be used for pressurized inhalers and that albuterol inhalers containing chlorofluorocarbon (CFC) propellants would be phased out by the end of 2008.

Dr. Correia provided the Department's clinical review of new information for this category. He noted one small study, not powered to detect a difference between active treatment, which demonstrated efficacy and safety for both albuterol and levalbuterol in comparison to placebo. The remainder of the study results discussed, including use of rescue/supplemental medication, are a result of multiple post-hoc analyses, with questionable clinical value due to study limitations. He discussed the new NAEPP guidelines in which albuterol, levalbuterol, and pirbuterol are all identified as treatments of choice for relief of acute symptoms and prevention of exercise-induced bronchospasm (EIB). He also indicated that guidelines currently state that albuterol and levalbuterol produce clinically comparable bronchodilation and systemic side effects at comparable doses, and that albuterol is identified as the preferred agent for use during pregnancy since it has the most safety-related data during human pregnancy.

Dr. Correia discussed the Global Initiative for Chronic Obstructive Lung Disease (GOLD) updated guidelines and noted there were not significant changes in medication recommendations. The guidelines state that for home management of COPD exacerbations, a short acting Beta ₂ agonist is preferred, but there is insufficient evidence to indicate a difference in efficacy between short acting bronchodilators, or between a metered dose inhaler with a spacer versus hand-held nebulizer.

In conclusion, Dr. Correia noted there is little new comparative information for this drug class since last reviewed, and inadequate evidence to demonstrate significant clinical superiority to justify preferential availability of any one product.

10. Re-review of the Beta ₂ Adrenergic Agent - Inhaled Long Acting therapeutic class

Drugs Affected: Brovana (arformoterol), Foradil (formoterol), Perforomist (formoterol), Serevent Diskus (salmeterol)

Dr. Rogler presented new recommendations from the NAEPP Guidelines for Asthma pertaining to the long-acting Beta ₂ agonists (LABA). She introduced the new agents receiving FDA approval since the last review of this class: Brovana (arformoterol) Inhalation Solution and Perforomist (formoterol) Inhalation Solution.

Dr. Correia provided the Department's clinical review of new information for this category. He spoke about the Health Advisory from the FDA that warned products containing LABAs may increase the chance of severe asthma episodes, and death when those episodes occur, and noted the warning does not yet extend to the use of these agents in COPD due to lack of evidence for that disease. He noted the controversy over the significance of the warning, reviewed some of the evidence behind the issue, and stated that, data currently indicate these severe adverse events have only become evident when larger populations were exposed to the drugs, with a potential relationship to increased dose. He discussed the place in therapy of these agents as addressed in the NAEPP Asthma Guidelines, noting that the guidelines identify the short-acting, rather than long-acting beta agonists as the treatment of choice for prevention of exercise induced bronchospasm. He also noted that all the agents in this class are indicated for use in COPD, and the solutions are only approved for use in COPD, not in asthma. He discussed the updated GOLD Guidelines, noting the recommendations for pharmacological treatments continue to rely on bronchodilators for symptomatic care. He also noted the guidelines state there is insufficient evidence to favor one LABA over another, nor is there a difference in clinical response between bronchodilators delivered via MDI with a spacer or a hand-held nebulizer. He concluded that no new information has been found to indicate any of these products demonstrate overall clinical advantage. As was stated last year, marginal potential differences in benefits seem to balance with risks between these drugs, with no evidence of overall clinical superiority to justify preferential availability of any of these products.

11. Re-review of the Inhaled Anticholinergic therapeutic class

Drugs Affected: Atrovent HFA (ipratropium), Combivent (ipratropium/albuterol), Duoneb (ipratropium/albuterol), ipratropium, ipratropium/albuterol, Spiriva (tiotropium)

Dr. Rogler indicated that inhaled anticholinergic medications are central to the management of COPD. She noted the new generic albuterol/ipratropium inhalation solution and the revised labeling for Combivent emphasizing the importance of shaking the inhaler vigorously for ten seconds to prevent inconsistent delivery of active ingredients.

Dr. Correia provided the Department's clinical review of new information for this category. He noted little if any significant new clinical information, and a lack of comparative evidence. He mentioned the place in therapy for drugs in this class as noted in both the Asthma and COPD guidelines. He also noted from the guidelines that in general, nebulized therapy is not usually appropriate for stable patients, unless shown to be better than conventional dose therapy in a particular patient. He concluded that although different products may be more appropriate at different points of disease process or progression, at this time there is no new evidence since the last review to support overall clinical superiority of any one of these products.

12. Re-review of the Inhaled Corticosteroid therapeutic class

Drugs Affected: Advair Diskus (fluticasone/salmeterol), Advair HFA (fluticasone/salmeterol), Aerobid/Aerobid-M (flunisolide), Asmanex (mometasone), Azmacort (triamcinolone), Flovent Diskus (fluticasone), Flovent HFA (fluticasone), Pulmicort (budesonide) Turbuhaler, Pulmicort (budesonide) Flexhaler, Qvar (beclomethasone), Symbicort (budesonide/formoterol)

Dr. Rogler discussed the new Pulmicort Flexhaler (budesonide inhalation powder) replacing the Turbuhaler, which is being phased out. She also discussed the new product Symbicort (budesonide/formoterol), including product strength, indications, dosing and the class warning for drug products containing LABAs. She noted the place in therapy for the inhaled corticosteroids according to the NAEPP Asthma Guidelines.

Dr. Correia provided the Department's clinical review of new information for this category. He discussed the new (budesonide/formoterol) combination product, noting the individual drugs are available separately, are equal in efficacy to the combination product when used together, and were reviewed last year. He discussed the recommendations of the new NAEPP Asthma Guidelines and the most recent COPD guidelines with regard to the place in therapy for the Inhaled Corticosteroids, and emphasized the Expert Panel Report Update #3 specifically does not currently recommend use of LABA or increased dosages with or without inhaled corticosteroids for acute exacerbations, as further studies are necessary in this area. He noted the most recent COPD guidelines continue to recommend bronchodilators as the primary treatment, with added inhaled corticosteroids only appropriate for symptomatic severe or very severe COPD (Stage 3 or 4) with repeated exacerbations. He concluded that although different products may be more appropriate at different points of disease process or progression, there is not adequate new evidence since the last review of clinical superiority of any one of these products to justify preferential availability.

13. Re-review of the Topical Immunomodulators therapeutic class

Drugs Affected: Elidel (pimecrolimus), Protopic (tacrolimus)

Drs. Correia and Rogler concurred no new evidence has been found to indicate that either of these products is more safe or effective overall.

14. Re-review of the Anti-Fungals (Onychomycosis) therapeutic class

Drugs Affected: Fulvicin U/F (griseofulvin), Grifulvin V (griseofulvin), Gris-PEG (griseofulvin), griseofulvin, itraconazole, Lamisil (terbinafine), Penlac (ciclopirox), Sporanox (itraconazole), terbinafine

Dr. Rogler noted the new generic medications in this class: terbinafine and ciclopirox. She found no other new clinical information since the last review of the class.

Dr. Correia noted no new clinical evidence was found to change the previous assessment of the drugs in this class. Any of the three oral products are effective and may have advantages for particular infections or patient populations, with none of these drugs demonstrating overall advantages for all cases. Dr. Correia also noted a new generic is available for the topical nail product, but the topical preparations are dramatically inferior, and of questionable effectiveness in resolving onychomycosis compared to the oral agents.

A Committee member asked about the success rate of the topical agents, and Dr. Correia indicated it depends on how you assess the success rate taking into consideration the success rate of the vehicle alone, and that test samples may have become contaminated with drug.

15. Re-review of the Anti-Virals (used in the treatment of Herpes) therapeutic class

Drugs Affected: acyclovir, famciclovir, Famvir (famciclovir), Valtrex (valacyclovir), Zovirax (acyclovir)

Dr. Rogler noted famciclovir as a new generic medication in this class. She found no other new clinical information since the last review of the class.

Dr. Correia provided the Department's clinical review of new information for this category. He reiterated that according to the CDC Guidelines for the Treatment of Sexually Transmitted Diseases published in 2006, all three of the drugs in the class may be used to treat initial and recurrent episodes of genital herpes, as well as provide suppressive therapy for both immunocompetent and HIV-infected patients. He clarified the data presented during the public comment period with regard to valacyclovir and the decrease in herpes transmission to uninfected sexual partners noting that the data represents a less than 2% decrease in disease transmission for eight months in heterosexual, monogamous, HIV-negative couples. He noted the differences in dosing for the drugs based on indication, and indicated that he is not aware of any evidence which demonstrates increased compliance between once or twice daily dosing. He noted that further research is needed in the area of HSV/HIV co-infection as most of the evidence currently available is from patients who were not taking highly active antiretroviral therapy. He also reiterated current CDC guidelines for dosing in immunocompetent patients, including dosing for initial and recurrent episodes, for suppression, including probable reduction in transmission of disease, and for coinfection with HIV, noting similarities in dosing between drugs. In conclusion, he stated no new comparative evidence was found to differentiate effectiveness between the three drugs, and all three products are effective and may have advantages for a specific use or patient population, but none significantly overall. He noted acyclovir is the only drug in the category with adequate pediatric data.

16. Re-review of the Injectable Immunomodulators therapeutic class

Drugs Affected: Enbrel (etanercept), Humira (adalimumab), Kineret (anakinra)

Dr. Gartlehner, UNC, presented an overview of the updated OHSU DERP Drug Class Review on Targeted Immune Modulators, dated October, 2006. He discussed new evidence, including head-to-head evidence, in the treatment of rheumatoid arthritis (RA), psoriatic arthritis and Crohn's disease. He also discussed new evidence with regard to adverse events and patient subgroups for drugs in this class. He noted no double-blind randomized trial compared one injectable immunomodulator to another. He indicated that available evidence suggests no differences in efficacy among drugs in this class for the treatment of RA, and evidence is insufficient to draw conclusions about the comparative effectiveness for other indications including juvenile RA and Crohn's disease, and the comparative safety and tolerability of the drugs in this class. He noted that rare but severe adverse effects can occur with the drugs in this class, and the long term effects of these drugs are currently unknown.

Dr. Rogler noted since the last review of this class, adalimumab has received an additional indication for Crohn's disease, and she discussed the dosing regimen for the new indication.

Dr. Correia provided the Department's clinical review of new information for this category. He reviewed the two main cytokine immune processes impacted by the biologic drugs under review. He mentioned a published retrospective case review identifying an increased risk with all biologics used to treat RA for non-melanotic skin cancer and melanoma. He also mentioned an observational study identifying increased risk of infection with the anti-TNF agents. He noted the new indication for adalimumab. He concluded no new comparative evidence was found to differentiate effectiveness between the three products, and any of the products are effective for the treatment of RA, while the TNF antagonists also have additional indications. He noted indirect evidence suggests the anti-TNF products seem to be more effective than anakinra, however, the anti-TNF products have also been associated with more serious adverse effects.

The Committee discussed the congestive heart failure data in the OHSU report, the use of these products in minority groups, specifically in patients with hepatitis B infection, the black box warning with regard to immune suppression, and the increased rate of infection and malignancy with these drugs.

E. Executive Session:

The Committee recessed the public session at 10:40 A.M. to go into executive session for review of financial information relating to the determination of preferred drugs in the following classes: Leukotriene Modifiers, Hepatitis C Agents, Third Generation Cephalosporins, Otic Fluoroquinolones, Anti-Emetics, Second Generation Antihistamines, CAIs, Phosphate Binders/Regulators, Topical Immunomodulators, Anti-Fungals, Anti-Virals, Injectable Immunomodulators. No official action was taken in the executive session. The executive session was recessed at 11:30 A.M.

The Committee recessed the public session at 2:00 P.M. to go into executive session for review of financial information relating to the determination of preferred drugs in the following classes: Inhaled Anticholinergics, Inhaled Corticosteroids, Beta ₂ Adrenergic Agents - Inhaled Short and Long Acting. No official action was taken in the executive session. The executive session was recessed at 2:50 P.M.

F. Recommendations of the Pharmacy and Therapeutics Committee:

The following recommendations developed by the P&T Committee are to be submitted to the Commissioner of Health for final determination.

Description of Recommendations	Commissioner's Final Decision
Proposal: Identification of preferred drugs in the category of Leukotriene Modifiers A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Accolate (zafirlukast), Singulair (montelukast) Non-preferred Drugs None B. The Committee unanimously recommended the following standard clinical questions be used as the basis for approving use of the non-preferred drug: Q: Has your patient experienced treatment failure with preferred drugs in the class? Q: Has your patient experienced an adverse drug reaction with preferred drugs in the class? Q: Is there a documented history of successful therapeutic control with a non-preferred drug and transition to a preferred drug is medically contraindicated?	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Hepatitis C- Pegylated Interferons A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs PEG-Intron (peginterferon alfa-2b), PEG-Intron Redipen (peginterferon alfa-2b), Pegasys (peginterferon alfa-2a), Pegasys Convenience Pack (peginterferon alfa-2a) Non-preferred Drugs None B. The Committee unanimously recommended the standard clinical questions be used as the basis for approving use of a non-preferred drug, should the Commissioner's final decision include a non-preferred drug.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Third Generation Cephalosporins A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Cedax (ceftibuten), cefdinir, cefpodoxime proxetil, Suprax (cefixime) Non-preferred Drugs Omnicef (cefdinir), Spectracef (cefditoren), Vantin (cefpodoxime proxetil) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Otic Fluoroquinolones A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Ciprodex (ciprofloxacin/dexamethasone), ofloxacin Non-preferred Drugs Cipro HC (ciprofloxacin/hydrocortisone), Floxin (ofloxacin) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Anti-Emetics A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs ondansetron, Zofran (ondansetron) Non-preferred Drugs Anzemet (dolasetron), Kytril (granisetron) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Second Generation Antihistamines A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs OTC loratadine products (i.e. Claritin), OTC loratadine D products (i.e. Claritin D) Non-preferred Drugs Allegra/Allegra-D (fexofenadine), Clarinex/Clarinex-D (desloratadine), fexofenadine, Semprex-D (acrivastine), Xyzal (levocetirizine), Zyrtec/Zyrtec-D (cetirizine) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process and again recommended one additional clinical question for specific product pediatric indications: Q: Is the patient under twenty-four (24) months of age?	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Cholesterol Absorption Inhibitors (CAIs) A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Zetia (ezetimibe) Non-preferred Drugs None	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Phosphate Binders/Regulators A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Fosrenol (lanthanum), Phoslo (calcium acetate), Renagel (sevelamer) Non-preferred Drugs None B. The Committee unanimously recommended the standard clinical questions be used as the basis for approving use of a non-preferred drug, should the Commissioner's final decision include a non-preferred drug.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Inhaled Short Acting Beta 2 Adrenergic Agents A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee recommended the following with a vote of 8 to 2: Preferred Drugs albuterol, Maxair Autohaler (pirbuterol), Proventil HFA (albuterol), Ventolin HFA (albuterol), Xopenex solution (levalbuterol) Non-preferred Drugs Accuneb (albuterol), Alupent (metaproterenol), metaproterenol, ProAir HFA (albuterol), Proventil (albuterol), Xopenex HFA (levalbuterol) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Inhaled Long Acting Beta 2 Adrenergic Agents A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Foradil (formoterol), Serevent Diskus (salmeterol) Non-preferred Drugs Brovana (arformoterol), Perforomist (formoterol) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Inhaled Anticholinergics A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Atrovent HFA (ipratropium), Combivent (ipratropium/albuterol), ipratropium, Spiriva (tiotropium) Non-preferred Drugs Duoneb (ipratropium/albuterol), ipratropium/albuterol B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Inhaled Corticosteroids A.Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Advair Diskus (fluticasone/salmeterol), Advair HFA (fluticasone/salmeterol), Asmanex (mometasone), Azmacort (triamcinolone), Flovent Diskus (fluticasone), Flovent HFA (fluticasone), Qvar (beclomethasone) Non-preferred Drugs Aerobid/Aerobid-M (flunisolide), Pulmicort (budesonide) Turbuhaler, Pulmicort (budesonide) Flexhaler, Symbicort (budesonide/formoterol) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process and again recommended one additional clinical question for specific product concerns related to pregnancy: Q: Is this prior authorization request due to concerns related to pregnancy?	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Topical Immunomodulators A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Elidel (pimecrolimus), Protopic (tacrolimus) Non-preferred Drugs None B. The Committee unanimously recommended the standard clinical questions be used as the basis for approving use of a non-preferred drug, should the Commissioner's final decision include a non-preferred drug.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Anti-Fungals A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee recommended the following with a vote of 7 to 3: Preferred Drugs ciclopirox, Grifulvin V tablet (griseofulvin), Gris-PEG (griseofulvin), griseofulvin, terbinafine Non-preferred Drugs Grifulvin V suspension (griseofulvin), itraconazole, Lamisil (terbinafine), Penlac (ciclopirox), Sporanox (itraconazole) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Anti-Virals A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs acyclovir, famciclovir, Valtrex (valacyclovir) Non-preferred Drugs Famvir (famciclovir), Zovirax (acyclovir) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended
Proposal: Identification of preferred drugs in the category of Injectable Immunomodulators A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following: Preferred Drugs Enbrel (etanercept), Humira (adalimumab) Non-preferred Drugs Kineret (anakinra) B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.	Approved as Recommended

G. Additional Discussion:

Ms. Jones reminded the public that all drugs currently covered by Medicaid remain available under the Preferred Drug Program and the determination of preferred and non-preferred drugs does not prohibit a prescriber from obtaining any of the medications covered under Medicaid.

H. Final Determinations:

The Commissioner has determined that the Medicaid program will require prior authorization under the Preferred Drug Program (PDP) for non-preferred drugs, as listed above, in the following classes: Leukotriene Modifiers, Hepatitis C - Pegylated Interferons, Third Generation Cephalosporins, Otic Fluoroquinolones, Anti-Emetics, Second Generation Antihistamines, Cholesterol Absorption Inhibitors, Phosphate Binders/Regulators, Inhaled Short Acting Beta-2 Adrenergic Agents, Inhaled Long Acting Beta-2 Adrenergic Agents, Inhaled Anticholinergics, Inhaled Corticosteroids, Topical Immunomodulators, Anti- Fungals, Anti-Virals, Injectable Immunomodulators.

Preferred Drugs will not require prior authorization

The impact of this final determination is as follows:

1. State Public Health Population:
   • Minimal effect on Medicaid enrollees, as a large majority of enrollees currently utilize preferred products.
   • Non-preferred products remain available when prior authorized.
2. Program Providers:
   • No impact on prescribers or pharmacies when utilizing preferred products. Prescribers, or their agents, will need to initiate the prior authorization process when ordering non-preferred products. Pharmacies will need to complete the prior authorization process for non-preferred products.
3. State Health Program:
   • Annual gross savings associated with these therapeutic classes under the PDP are estimated at $46 M. The savings are achieved through changes in utilization to equally effective and less expensive drugs through the receipt of supplemental rebates from pharmaceutical manufacturers.

Final Determinations Posted 1/16/08